Argentum Infection Prevention & Control Announcements

Last night, the U.S. Food and Drug Administration made an amendment to the Emergency Use Authorization (EUA) for the Pfizer COVID-19 vaccine allowing for a booster dose to be given at least six months after completion of its primary series in those 65 years of age and older. They also authorized the booster for those 18+ who are at high risk of severe COVID-19 and those whose occupations put them at risk, such as "health care workers, teachers and day care staff, grocery workers and those in homeless shelters or prisons, among others,” said acting FDA Commissioner Dr. Janet Woodcock.

Today, the FDA’s Vaccines and Related Biological Products Advisory Committee met and voted unanimously to recommend Emergency Use Authorization (EUA) for a booster dose of the Pfizer COVID-19 vaccine to be given six months after full vaccination for those 65 and older and those at high risk of severe illness due to COVID-19. They also informally suggested that health care workers be considered for the booster dose.

Today, the U.S. Food & Drug Administration (FDA) fully approved the Pfizer-BioNTech COVID-19 vaccine, which will now be marketed as Comirnaty, for the prevention of COVID-19 in those 16 years of age and older.

Wednesday, the CDC issued a joint statement with other federal regulatory agencies on plans for an additional booster dose of the Pfizer or Moderna mRNA COVID-19 vaccines. Need for a booster with the Johnson & Johnson vaccine is still being evaluated.

The CDC updated its mask guidance today for people who are fully vaccinated in the general public. Guidance for healthcare professionals remains unchanged at this time. The CDC now recommends wearing a mask indoors in any of these conditions:

Visitation is essential to the health and well-being of senior living residents. Argentum's latest guidance, "Model Visitation Protocols For Vaccinated Senior Living Communities," provides protocols, considerations, and general practices designed specifically for visitation in the variety of spaces and circumstances in senior living communities. This guidance was compiled by clinical experts, risk managers, and other stakeholders who have in-depth knowledge of senior living. 

Today, the CDC has released the first set of public health recommendations for those who are fully vaccinated. This guidance will be updated and expanded as more information becomes available.

Today, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the single-dose Janssen COVID-19 vaccine from Johnson & Johnson. This authorization suggests that the benefits outweigh its risks for use in individuals 18 of age or older and permits the vaccine to be distributed in the U.S., making it the third vaccine available in the country.

“After a thorough analysis of the data, the FDA’s scientists and physicians have determined that the vaccine meets the FDA’s expectations for safety and effectiveness appropriate for the authorization of a vaccine for emergency use,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.

The CDC has launched a new COVID-19 Data Tracker module that includes state-specific vaccine administration information for the federal Pharmacy Partnership for Long-Term Care program. The module includes an interactive U.S. map and data, which are updated daily.

As of yesterday, the CDC reported that just under 4.4 million doses of the COVID-19 vaccine had been distributed for use in long-term care facilities. On average, 137,000 doses of vaccine are being distributed for use by this sector each day. Previously, the CDC estimated a total of 3 million people needing vaccines within this sector and as such, they have already distributed 146% of the doses needed for skilled nursing facilities, assisted living communities, and other long-term care settings.